NCT01803685

Brief Summary

This register study will collect the treatment information of the intracranial arteriovenous malformation patients in China. We aim to understand the current treatment situation of the disease in China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

2.3 years

First QC Date

March 1, 2013

Last Update Submit

March 1, 2013

Conditions

Intracranial Arteriovenous Malformations

Keywords

Intracranial Arteriovenous MalformationsSurgical removalEndovascular embolismStereotaxic radiosurgeryOutcomes

Outcome Measures

Primary Outcomes (1)

  • modified Ranking Scale

    The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead

    six months after operation

Secondary Outcomes (1)

  • Treatment complications

    six months after treatment

Study Arms (5)

Surgical treatment

Surgical resection of intracranial arteriovenous malformations.

Stereotaxic radiosurgery

Deliver a relatively high dose of focused radiation precisely to the arteriovenous malformations.

Endovascular treatment

Deliver embolic materials to the feeding arteries or the nidus by microcatheters

Comprehensive treatment

Use two or three methods ( Surgical treatment stereotaxic radiosurgery endovascular treatment ) to cure the intracranial arteriovenous malformations

Conservative treatment

Patients refused to any of the treatment above

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients that diagnosed of intracranial AVM by DSA/CT/MRI

You may qualify if:

  • All the patients that diagnosed of intracranial AVM by DSA/CT/MRI
  • All patients gave written informed consent

You may not qualify if:

  • patients refuse to attend the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCentral Nervous System Vascular MalformationsNervous System MalformationsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesIntracranial Arterial DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Shuo Wang, MD

    Beijing Tiantan Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 4, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

March 4, 2013

Record last verified: 2013-03

Locations

CN(1)